Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-03-14 @ 7:30 PM
Study NCT ID:
NCT01790893
Status:
UNKNOWN
Last Update Posted:
2014-06-16
First Post:
2013-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Presumed Ocular Histoplasmosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006660', 'term': 'Histoplasmosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2013-02-11', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'OCT changes', 'timeFrame': 'baseline to 12 months', 'description': 'Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT'}], 'primaryOutcomes': [{'measure': 'ocular and systemic adverse events', 'timeFrame': 'through Month 12', 'description': 'The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'Months 3, 6, 9 and 12', 'description': '* Mean change in BCVA from Baseline\n* Proportion of subjects gaining \\>5,10 and 15 letters\n* Proportion of subjects losing \\>5, 10 and 15 letters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Histoplasmosis'], 'conditions': ['Ocular Histoplasmosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.retinaky.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.\n* Active CNV may also be defined as demonstrating active subretinal hemorrhage.\n* ETDRS Best corrected visual acuity 20/20-20/320.\n* willing and able to comply with all study clinic visits and study related procedures.\n* Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.\n* Provide signed informed consent\n* Able to understand and complete study related questionnaires\n\nExclusion Criteria:\n\n* Under 18 years of age\n* CNV due to other causes than Presumed Ocular Histoplasmosis\n* Previous treatment in the study eye within 6 months prior to Day 1\n* More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months\n* Any clinical evidence of any other ocular condition other than Ocular histoplasmosis\n* History of allergy to fluorescein\n* Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women\n* Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.\n* Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy'}, 'identificationModule': {'nctId': 'NCT01790893', 'acronym': 'HANDLE', 'briefTitle': 'Treatment for Presumed Ocular Histoplasmosis', 'organization': {'class': 'OTHER', 'fullName': 'Retina Associates of Kentucky'}, 'officialTitle': 'Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)', 'orgStudyIdInfo': {'id': 'IND 117497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intravitreal aflibercept injection', 'description': 'Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection.\n\n.', 'interventionNames': ['Drug: aflibercept']}, {'type': 'EXPERIMENTAL', 'label': 'intravitreal aflibercept', 'description': 'Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.', 'interventionNames': ['Drug: aflibercept']}], 'interventions': [{'name': 'aflibercept', 'type': 'DRUG', 'armGroupLabels': ['intravitreal aflibercept', 'intravitreal aflibercept injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jared Gardner', 'role': 'CONTACT', 'email': 'jgardner@southeastretina.com', 'phone': '706-650-0061'}, {'name': 'Courtney Caulder', 'role': 'CONTACT', 'email': 'ccaulder@southeastretina.com', 'phone': '706-650-0061'}, {'name': 'Dennis Marcus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Harinderjit Singh, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Southeast Retina', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Holcomb', 'role': 'CONTACT', 'email': 'dholcomb@retinaky.com', 'phone': '859-264-2905'}, {'name': 'John W. Kitchens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William J Wood, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tom Stone, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rick Isernhagen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrew Moshfeghi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Retina Associates of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Kingdon', 'role': 'CONTACT', 'phone': '513-569-3669'}, {'name': 'Daniel Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Petersen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Sisk, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Foster, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Riemann, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brian Toussaint, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Diana Holcomb, COA', 'role': 'CONTACT', 'email': 'dholcomb@retinaky.com', 'phone': '859-264-2905'}], 'overallOfficials': [{'name': 'John W Kitchens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Retina Associates of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Kitchens, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'John Kitchens, MD', 'investigatorAffiliation': 'Retina Associates of Kentucky'}}}}